Disposable catheter

ABSTRACT

A catheter formed of an elongated, hollow tube having a sealed, separate air passageway formed integrally of the tube and extending from a point near the forward end of the tube to an integral air inlet nozzle located near the rear end of the tube and extending outwardly therefrom. An inflatable barrel shaped cuff is mounted upon and encircles the tube near its forward end, there being an opening in the tube wall communicating the interior of the cuff with the air passageway for inflating and deflating the cuff. A cup shaped seal is also mounted upon the tube and is frictionally secured thereto by integral springy flanges which permit forwardly sliding the seal upon the tube but which resists rearward sliding of the seal.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation-in-part application of copending U.S.Pat. application Ser. No. 139,725, filed May 3, 1971, for "DisposableCatheter," now abandoned.

BACKGROUND OF THE INVENTION

Catheters generally comprise an elongated tube for insertion into a bodycavity and an inflatable cuff or sealing device for sealing against thebody cavity opening around the tube to prevent fluid leakage around thetube. An example of such a catheter is found in my prior U.S. Pat. No.3,417,753 granted Dec. 24, 1968.

In the past, catheters, along with other medical appliances, were reusedand sterilized after each use. However, due to the difficulties ofsterilization and the expenses of labor in connection with any cleaningand resterilizing of medical appliances, efforts have been made to makemany medical appliances disposable, that is, single use. This isparticularly true with regard to catheters primarily designed forinsertion into anal cavities. It has been medically proven that it isimpossible to provide that degree of sterilization of anal cathetersnecessary to prevent the transference of pathogens from one patient oruser to another. Thus, anal catheters must be disposable. This means,that the construction must be so inexpensive that is more economical tothrow away the appliance rather than to clean and reuse it. However, theappliance must be made well so that it functions properly on its firstand only use.

The foregoing patent illustrates an example of a catheter made forsingle use. However, it is desirable to make improvements upon suchcatheter particularly to reduce its overall diameter and to eliminatetubes or other items which are separate from the basic catheter tube, inorder to facilitate ease of entry into and withdrawal out of the bodycavities. Thus, the invention herein relates to a disposable or singleuse catheter which is an improvement over prior catheters.

SUMMARY OF THE INVENTION

The invention herein relates to a disposable or single use catheterformed of a tube having an integral, internal air passageway whichutilizes only a small portion of the cross-section of the tube. The tubecarries a barrel shaped inflatable cuff of normally small diameter, butwhich may be easily inflated into an adequate diameter for sealingagainst the wall of a body cavity, around the tube. The tube alsocarries a separate slidable plastic shield for sealing against the bodyarea defining the opening within which the catheter tube is inserted.The shield includes means for facilitating placement thereof on theexterior of the tube or shank.

The tube also has means for positive stop positioning formed on theexterior thereof. The catheter also includes means for facilitatingfluid flow into a body cavity through the head of the tube.

The invention herein contemplates forming the catheter tube with itsbarrel-shaped cuff of simple and inexpensive construction, while at thesame time having the structural strength and configuration to adequatelyperform its function.

These and other objects and advantages of this invention will becomeapparent upon reading the following description of which the attacheddrawings form a part. In the drawing like reference characters refer tolike parts throughout the several views in which:

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is an elevational view of a catheter assembly;

FIG. 2 is an enlarged, fragmentary cross-sectional view of a catheterassembly;

FIG. 3 is a cross-sectional view of the catheter tube, taken in thedirection of arrows 3--3 of FIG. 2;

FIG. 4 is a perspective view of the inflatable cuff;

FIG. 5 is a cross-sectional view taken in the direction of arrows 5--5of FIG. 4 of the cuff;

FIG. 6 is a fragmentary view showing the connection or sealing betweenthe cuff and the tube;

FIG. 7 is a perspective view of the cup-shaped, external shield;

FIG. 8 is an enlarged, fragmentary view of the means for mounting theshield upon the catheter tube;

FIG. 9 is a side elevational view of an alternate embodiment of acatheter tube, and

FIG. 10 is a perspective view of an alternate embodiment of the externalshield.

DESCRIPTION OF THE PREFERRED EMBODIMENTS

In copending U.S. Patent application Ser. No. 139,725, the disclosure ofwhich is hereby incorporated by reference, there is described a firstembodiment of the present invention, and is detailed in FIGS. 1-8,hereof.

FIGS. 1 and 2 illustrate the catheter assembly 10 of the firstembodiment and which includes an elongated, thin wall, hollow tube 11,formed of a suitable plastic material. The central opening of the tubeforms a fluid passageway 12 which extends from the forward rounded orbulbous end or head 13 through which it opens at 14, to the rear oropposite end 15 of the tube 11. The rear end of the tube is formed witha suitable hose grip configuration 16 over which a conventionalrubber-like hose (not shown) may be slipped and frictionally engaged andretained in place.

As shown in FIGS. 2 and 3 a transversely arranged, longitudinallyextending internal flat strip 17 is integrally formed within the tube11. The strip 17 is closely adjacent to a segment of the tube wall, asshown, with the long edges of the strip integral with the wall. Theforward end 18 of the strip 17 is integral with the tube wall near theforward end of the tube. Likewise, the rear end 19 of the strip 17 isintegral with the tube wall near the rear end 15 of the tube. Thus, thestrip, in conjunction with a segment of the wall of the tube, defines aclosed air passageway 20 which, as illustrated in FIG. 3, occupies arelatively minor portion of the cross-section of the interior of thetube, so that the major portion of the interior cross-section isunobstructed for fluid passage through the passageway 12.

The air passageway 20 opens at 21 into an integral air nozzle 22 whichextends angularly outwardly of the tube near its rear end 15. A hosegrip configuration 23 (FIG. 1) is formed on the end of the air nozzle 22so that a rubber-like tube or other suitable hosing (not shown) may beslipped over and frictionally gripped upon the nozzle 22. The hosing isattached at its other end to a source of compressed air (not shown)which delivers or supplies compressed air into the air passageway 20. Asis described hereinafter, the compressed air is employed to inflate asuitable cuff which aids fluid retention in a body cavity.

Referring to FIG. 2, air opening 24 is formed in the tube wall at theforward end of the air passageway 20. The area around the air opening 24is covered by an inflatable cuff 25. The cuff 25 is, preferably, formedof an air impervious, inflatable, resilient and flexible material, suchas latex or a rubber-like material. In the embodiment shown in FIGS.1-8, the cuff 25 has a central barrel-shaped portion 26 and integral,opposed short cylinder end portions 27. Annular grooves 28 (FIG. 6) areformed in the tube wall beneath the cuff cylinder portions 27, O-ringsor O-ring seals 29 are provided to surround the cylinder portions 27 andto be positioned over the grooves 28. The seals 29 frictionally anchorand seal the cylinder portions to the tube wall 11.

The barrel-shaped portion 26 of the cuff 25 is provided with a pluralityof inwardly directed pleats or flutes 30 (see FIG. 5). These pleats 30extend the full length of the barrel-shaped portion 26. They invert whenthe cuff is inflated to permit the relatively small diameter uninflatedcuff 25 to expand into a substantial inflated diameter.

As best depicted in FIGS. 2 and 7, for sealing against the body portionsurrounding the entry to a body cavity, a shield 35 is mounted upon thetube 11. The shield 35 is mounted below the cuff 25 and engages the bodyportion surrounding the cavity. The shield 35 is rearwardly andoutwardly curved, relative to the tube 11, and forms a cup shape portion36. The shield 35 has central opening 37 surrounded by a rearwardlydirected hub portion 38 through which the tube 11 is closely fitted.Springy fingers or flanges 39 integral with the hub 38 extend rearwardlytherefrom. The flanges 39 frictionally engage and grip against the tube11. The shield is formed of a springy, relatively flexible plasticmaterial which, while being stiff enough to maintain its normal shape,may be sufficiently bent and flexed to conform more closely to the bodyportion against which it engages.

The spring fingers or flanges 39 are tapered inwardly relative to theaxis of the tube to frictionally grip against the tube wall, asillustrated in FIG. 8. Thus, the shield may be easily slid towards theforward end or head of the tube but resists sliding backwards towardsthe rear end of the tube due to the increase in frictional engagementbetween the fingers or flanges and the tube wall.

Referring now to FIGS. 9 and 10, there is depicted therein an alternateembodiment of the present invention. In this embodiment there isprovided an elongated tube or shank 111 having a central fluidpassageway 112. The passageway 112 extends from the forward end or head113 of the tube 111 to the rearward end 114 of the tube. The internalconfiguration of the tube is the same as hereinabove described includingthe air passageway in communication with a cuff 115 through an airnozzle 116. A hose 117 is connected to the nozzle 116 and is grippedthereonto by suitable gripping means 118. The gripping means 118 isanalogous to the grip configurations 23 and 16 of the hereinbeforedescribed embodiment.

The hose 117 is connected at its other end to a source of compressed airor the like (not shown) for inflating the cuff 115 through the airpassageway.

In order to facilitate fluid flow through the fluid passageway and inaccordance with the present embodiment a plurality of fluid deliveryapertures 119 are circumferentially disposed about the tube 111proximate the head 113. A central fluid delivery apertures 120 is alsoprovided at the terminus of the fluid passageway 112. By providing aplurality of fluid delivery apertures 119, 120, the fluid flow pressureof the fluid exiting from the tube is greatly decreased. Concomitantly agreater volume of fluid can be introduced into a body cavity with lessdiscomfort to the body.

As shown in FIG. 9, the tube 111 has formed on the exterior thereofpositive stop positioning means 121. The positive stop positioning meansgenerally comprise at least one forwardly directed bead 122. The bead122 tapers outwardly from the tube 111, as at 123, and thereby defines aledge 124 which extends circumferentially around the tube 111.

The ledge 124, acts as a barrier to limit or retard any motion of theshield 125 toward the rear 114 of the tube 111 in a manner describedsubsequently. The bead 122 may be integrally formed, such as by moldingor the like, or otherwise affixed to the exterior of the tube 111 in themedial portion thereof. A plurality of beads 122 are provided toaccommodate varying placements of the shield 125.

In the present embodiment of the invention and as shown in FIG. 10, theshield 125 also includes means 126 for mounting the shield on the tube111. The means 126 generally comprises an elongated slot or cut-outportion 127. The slot 127 is provided along the cup-shaped portion 128as well as through the hub portion 129.

Because of the materials used to manufacture the shield, the mountingthereof is facilitated by the slot 127. The slot affords flexure of theshield to enable its mounting either between two beads, or between abead and the cuff 115. The resiliency of the shield maintains itsfrictional mounting on the tube. In order to insure that the shieldremains locked around the tube means 136 are provided. The means 136generally comprises a male-female coupling 137, 138 formed on theinterior surface of the cup-shaped portion of the shield 127 proximatethe area of the slot 127. Preferably, the coupling 137, 138 is a detentearrangement which functions in a known manner. Because of theflexibility of the shield engagement and interlocking of the coupling137, 138 is possible. Moreover, by interlocking the shield anypossibility of the shield flexing and sliding off the tube is prevented.In all other respects, the shield 125 is the same as the shield 35hereinbefore described.

It is seen that, in accordance with this embodiment of the invention, ifthe shield 125 moves toward the rear 114 of the tube 111, the flanges130 of the shield 125 will abut and engage a ledge 124 to prevent anymovement of the shield therepast, thus providing positive stoppositioning of the shield.

Because the catheter hereof is primarily intended for insertion into ananal cavity, the shield provides two important functions. First, theshield functions as a safety means to prevent and inhibit prematurefluid leakage out of the anal cavity. Secondly, the shield functions asa safety stop if the cuff is improperly positioned or if the user orpatient attempts to expel the cuff with internal pressure. Thus, theshield is critical to the overall efficacy and efficiency of the presentcatheter.

Referring again to FIG. 9, the cuff 115 used herein can comprise thefluted cuff 25 heretofore described or any other suitably configuredcuff. In the embodiment of FIG. 9, the cuff 115 includes a centraltoroidal portion 131 and integrally formed opposed elongate portions 132and 133, respectively. The elongate portion 133 can be inverted withinthe toroidal portion 131 and clamped in the annular groove 134 throughan O-ring seal, as hereinbefore described.

Similarly, the elongate portion 132 can be clamped in the annular groove135 through an O-ring seal (now shown).

It is to be understood though, that the heretofore described fluted cuffcan be used with equal efficacy in this embodiment and vice versa.

It will be appreciated by those skilled in the art, that with thepresent invention there is provided means for facilitating fluid flow,means for mounting the shield, and means for positive stop positioningthe shield, all of which facilitate the use and deployment of adisposable catheter.

OPERATION

In operation, a rubber hose is assembled to the rear end configurationof the tube for the passage of fluids. A separate rubber hose or tube isconnected to the air nozzle, frictionally engaging the grip portion 23of the nozzle. Air is pumped through the air passageway by means of asuitable hand pump or the like, to inflate the barrel-shaped or toroidalportion of the cuff. This is done after the catheter tube is insertedinto the body cavity the required distance. Thereafter, the shield 35 isslid towards, against and into snug contact with the body portionsurrounding the entrance to the body cavity where it functions to limitthe leakage of fluid around the outside of the tube. The shield resistssliding backwards and remains in place after contacting the body portionand is aided and abetted by the positive stop positioning means. Forremoval, air is permitted to escape out of the nozzle to deflate thecuff, and the tube is withdrawn from the body cavity.

With the foregoing construction, the cuff inflates uniformly andsymmetrically about its center axis, with its wall thickness remaininguniform. This is an improvement over the prior catheters which have atendency to inflate non-symmetrically and with corresponding bulges andnon-uniform wall thicknesses.

Having fully described an operative embodiment of this invention I nowclaim:
 1. A catheter comprising:an elongated hollow tube having aforward end and a rearward end, the forward end being provided with aplurality of apertures to facilitate fluid delivery to a body cavity, afirst opening in the tube wall proximate the forward end thereof, asealing cuff mounted upon the tube over the area including the firstopening, the sealing cuff comprising a thin walled, air impervious,resilient rubber-like material, the tube extending through the cuff andthe cuff end portion being sealed to the tube such that the cuff may beinflated to an enlarged ring-shape co-axial with the tube for sealing abody cavity within which the tube is inserted; a second opening in thetube wall near the rearward end thereof; means disposed within the tubefor interconnecting the first and second openings, a rearwardly andoutwardly curved shield mounted below the cuff for sealing the bodycavity, the shield including a central opening and having a rearwardlydirected hub portion through which the tube is fitted, a plurality offingers integrally formed with the hub and extending rearwardlytherefrom, the fingers permitting forward sliding of the shield whileresisting rearward movement of the shield, means for mounting the shieldon the tube, the mounting means including an elongated slot providedthrough the shield and a coupling means for closing the slot, positivestop positioning means formed on the exterior of the tube, the meanscomprising at least one forwardly directed bead tapering outwardly fromthe tube, and wherein the openings and the means for interconnecting theopenings cooperate to define an air inlet for flowing pressurized airinto and for discharging air from the cuff to inflate and deflate,respectively, the cuff after the tube is inserted into the body cavity..Iadd.
 2. A catheter comprising:an elongated hollow tube having aforward end and a rearward end, the forward end being provided with aplurality of apertures to facilitate fluid delivery to a body cavity; afirst opening in the tube wall proximate the forward end thereof; asealing cuff mounted upon the tube over the area including the firstopening, the sealing cuff comprising a thin walled, air impervious,resilient rubber-like material; the tube extending through the cuff andthe cuff end portion being sealed to the tube such that the cuff may beinflated to an enlarged ring-shape co-axial with the tube for sealing abody cavity within which the tube is inserted; a second opening in thetube wall near the rearward end thereof; means disposed within the tubefor interconnecting the first and second openings; said sealing cuffcomprising a cuff central portion with integral, co-axially aligned,short, opposite cylindrically-shaped cuff end portions; upon deflationof said sealing cuff, the circumference of said cuff central portion ofsaid sealing cuff is only slightly greater than the circumference of themajor portion of said elongated hollow tube; said sealing cuff has atleast one fold therein which inverts when said sealing cuff is inflatedto permit the relatively small diameter uninflated sealing cuff toexpand to a substantial inflated diameter; a rearwardly and outwardlycurved shield mounted below the cuff for sealing the body cavity, theshield including a central opening and having a hub portion throughwhich the tube is fitted; means for mounting the shield on the tube, themounting means including an elongated slot provided through the shieldand a coupling means for closing the slot; and wherein the openings andthe means for interconnecting the openings cooperate to define an airinlet for flowing pressurized air into and for discharging air from thecuff to inflate and deflate, respectively, the cuff after the tube isinserted into the body cavity. .Iaddend. .Iadd.
 3. A catheter accordingto claim 2, wherein:said shield is disposed between said sealing cuffand said second opening in said tube wall; and said shield has an outersurface which faces said sealing cuff and which has substantially theshape of a surface of revolution. .Iaddend.